NCT05624164 Microfracture at Proximal Humerus Lateral to Footprint Could Enhance the Rotator Cuff Healing
| NCT ID | NCT05624164 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Affiliated Hospital of Nantong University |
| Condition | Rotator Cuff Tears |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 88 participants in total. It began in 2022-10-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to test whether there is any effect on rotator cuff healing by making microfracture at the lateral side of the footprint. The main question it aims to answer are: * \[whether the lateralized microfracture could decrease the retear rate after arthroscopy rotator cuff repair.\] * \[whether the lateralized microfracture could improve the functional recovery after arthroscopy rotator cuff repair.\] Participants with medium to larger size rotator cuff tears will be randomly assigned to the study group treated with lateralized microfracture immediately after arthroscopy rotator cuff repair or the control group treated with conventional arthroscopy rotator cuff repair without microfracture.
Eligibility Criteria
Inclusion Criteria: 1. Medium to large Rotator cuff tear(1cm-5cm) diagnosed by MRI 2. Patients can complete the follow-up and comply with all post-operative rehab instructions 3. Failure of non-operative treatment for at least 3 months Exclusion Criteria: 1. Revision rotator cuff surgery 2. Partial thickness rotator cuff tears 3. Small (less than 1cm) and Massive (greater than 5cm) rotator cuff tears 4. Disease history of the affected shoulder 5. Systemic immune diseases 6. Irreparable rotator cuff tear
Contact & Investigator
Yucheng Sun, Ph.D
PRINCIPAL INVESTIGATOR
Affiliated Hospital of Nantong University
Frequently Asked Questions
Who can join the NCT05624164 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Rotator Cuff Tears. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05624164 currently recruiting?
Yes, NCT05624164 is actively recruiting participants. Contact the research team at tdfykjc@163.com for enrollment information.
Where is the NCT05624164 trial being conducted?
This trial is being conducted at Nantong, China, Nantong, China.
Who is sponsoring the NCT05624164 clinical trial?
NCT05624164 is sponsored by Affiliated Hospital of Nantong University. The principal investigator is Yucheng Sun, Ph.D at Affiliated Hospital of Nantong University. The trial plans to enroll 88 participants.